31 Dental Implants - 510K Submissions

31 Dental Implants
Statement Letter:
Ms. Jacquelyn A. Hughes
Director, Regulatory Affairs & Quality Assurance
Implant Innovations, Incorporated
4555 Riverside Drive
Palm Beach Gardens, Florida 334 10
Re: KO30614
Trade/Device Name: 31 Dental Implants
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: I11
Product Code: DZE
Dated: June 19, 2003
Received: June 20, 2003
Dear Ms. Hughes:
We have reviewed your Section 5 1 O(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class TI (Special Controls) or class I11 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 2 1 , Parts 800 to 898. In addition, FDA may pub1i:jh further announcements concerning your device in the Federal Register. -
Please be advised that FDA4's issuance of a substantial equivalence determination does not mean that FDA has made (a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 1 CFR Part 807); labeling (2 1 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.
This letter will allow you 'to begin marketing your device as described in your Section 5 1 O(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2 1 CFR Part 80 l), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2 1 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http ://www. fda. gov/cdrh/tlsma/dsmamain. html
Sincerely yours,
Susan Runner, DDS, MA
Interim Director
Division of Anesthesiology, General Hospital
Office of Device Evaluation
Center for Devices and
Radiological Health
Summary Information:
Implant Innovations, Inc. (3i)
Mrs. Jacquelyn A. Hughes, RAC
Implant Innovations, Inc.
Person 4555 Rivwside Drive
Palm Beach Gardens, FL 33410
jhughes @3implant.com
(561) 776-6819
Date Prepared June 19,2:003
Device Name 3i Dental Implants
Device Description:
This 5 10(k) requests an expansion of the indications for use of all externally and internally hexed 3i dental implants to include immediate loading procedures in the mandible when using a minimum of four (4) splinted
implants 2lOmm in length. Standard, commercially available 3i abutments and screws can be used with 3i dental implants in immediate loading procedures. Several new components will complement the standard line for the clinicians use as necessary in immediate occlusal loading.
Indications for Use:
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in paitially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures. In addition, when a minimum of 4 implants, 3 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.